Spritam (levetiracetam)

Levetiracetam therapy should not be discontinued abruptly.

When switching from oral to IV levetiracetam therapy, the initial total daily dosage of IV levetiracetam should be equivalent to the daily dose and frequency of oral levetiracetam. At the completion of the IV treatment period, the patient may be switched back to oral levetiracetam at the equivalent daily dose and frequency that was administered IV.

Levetiracetam is administered orally (as immediate-release tablets, extended-release tablets, or oral solution). The drug also may be administered by IV infusion in patients in whom oral therapy is temporarily not feasible.

Commercially available levetiracetam conventional (immediate-release) tablets, extended-release tablets, oral solution, and IV formulations have been shown to be bioequivalent.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Levetiracetam is contraindicated in patients with known hypersensitivity to the drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in 1% or more of adults receiving oral levetiracetam (as conventional preparations) for adjunctive management of partial seizures include somnolence, asthenia, headache, infection, dizziness, pain, pharyngitis, depression, nervousness, rhinitis, anorexia, ataxia, vertigo, amnesia, anxiety, emotional lability, hostility, paresthesia, increased cough, sinusitis, and diplopia.

Adverse effects occurring in 2% or more of pediatric patients older than 4 years of age receiving oral levetiracetam (as conventional preparations) for adjunctive management of partial seizures include headache, vomiting, nasopharyngitis, somnolence, fatigue, aggression, upper abdominal pain, cough, nasal congestion, decreased appetite, dizziness, pharyngolaryngeal pain, abnormal behavior, dizziness, irritability, diarrhea, lethargy, insomnia, head injury, anorexia, agitation, constipation, influenza, contusion, fall, depression, altered mood, ear pain, conjunctivitis, gastroenteritis, rhinitis, joint sprain, arthralgia, neck pain, sedation, labile affect, anxiety, confusional state, and mood swing. The most common adverse effects in patients younger than 4 years of age were somnolence and irritability.

The adverse effect profile of levetiracetam (as conventional preparations) in patients with myoclonic seizures or primary generalized tonic-clonic seizures is generally similar to that of patients with partial seizures.

Adverse effects occurring in 5% or more of patients receiving extended-release levetiracetam tablets for adjunctive management of partial seizures include influenza, somnolence, irritability, nasopharyngitis, dizziness, and nausea.

Adverse effects associated with IV levetiracetam generally appear to be consistent with those associated with oral administration of the drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of levetiracetam immediate-release tablets, oral solution, and injection for the management of partial onset seizures have not been established in pediatric patients younger than 1 month of age. Behavioral abnormalities (e.g., paranoia, confusional state, increased aggression) have been observed in pediatric patients 4-16 years of age with partial onset seizures receiving the drug.

Safety and efficacy of levetiracetam immediate-release tablets, oral solution, and injection for the management of myoclonic seizures have not been established in pediatric patients younger than 12 years of age.

Safety and efficacy of levetiracetam immediate-release tablets, oral solution, and injection for the management of primary generalized tonic-clonic seizures have not been established in pediatric patients younger than 6 years of age.

Safety and efficacy of extended-release levetiracetam tablets have not been established in pediatric patients younger than 12 years of age. Use of the extended-release tablets in children 12 years of age and older is supported by a placebo-controlled study using the immediate-release preparation in patients 4-16 years of age.

Safety and efficacy of levetiracetam in sodium chloride injection have not been established in pediatric patients younger than 16 years of age.

Available data in pregnant women have not identified a drug-associated risk of major birth defects or miscarriage with levetiracetam. In animal reproduction studies, developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) was observed.

Seizure control during pregnancy should be carefully monitored; decreased plasma concentrations of levetiracetam may occur during pregnancy and dosage adjustments may be necessary to maintain clinical response.

A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to anticonvulsant drugs during pregnancy. Encourage women who are taking levetiracetam during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 or https://www.aedpregnancyregistry.org.

Levetiracetam is distributed into human milk. It is not known whether the drug has any effects on the breastfed infant or on milk production. Consider the benefits of breastfeeding along with the mother's clinical need for levetiracetam and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Controlled clinical studies evaluating levetiracetam have not included sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. No substantial differences in safety have been observed in geriatric patients relative to younger adults.